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FDA Urged to Boost Efforts Against Economic Adulteration of Food and Drugs

Tuesday, November 29, 2011
Sandler, Travis & Rosenberg Trade Report

In a report submitted to Congress Oct. 24, the Government Accountability Office called on the Food and Drug Administration to take additional action against the economic adulteration of food and drugs. Although FDA does not currently have a working definition of economic adulteration, a shortcoming that the report urges the agency to remedy, GAO defines it as the fraudulent, intentional substitution or addition of a substance in a product to increase the apparent value or reduce the cost of production of that product. Economic adulteration includes the dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution. The report notes that in recent years the U.S. has experienced several public health crises suspected to have been caused by this activity, including melamine in pet food and oversulfated chondroitin sulfate in the blood thinner heparin.

According to the report, FDA primarily approaches economic adulteration as part of its broader efforts to combat adulteration in general, such as efforts to ensure the safety of imported products. When FDA detects any form of adulteration that poses an adverse public health effect it can conduct an investigation, request a recall to get the product off the market and take enforcement action. While the Federal Food, Drug and Cosmetic Act does not distinguish among motives or require motive to be established to determine whether a product is adulterated, a senior FDA official told GAO that there is value in making a distinction between economic adulteration and other forms to guide the agency’s thinking about how to be more proactive in addressing this issue. While some FDA entities have undertaken efforts that specifically focus on economic adulteration, GAO notes, they have not always communicated or coordinated these efforts and FDA has not issued specific written guidance on how its centers and offices should approach or address their economic adulteration efforts.

The report cites several challenges to detecting and preventing economic adulteration. Globalization has led to an increase in the variety, complexity and volume of imported food and drugs, which complicates FDA’s task of ensuring their safety. In addition, an increase in supply chain complexity can make it difficult to trace an ingredient back to its source. Another frequent problem is gathering information from industry , such as information on potentially adulterated ingredients, which can be difficult due to a reluctance to share proprietary information.

Greater oversight and information sharing are two options GAO identifies to improve FDA’s ability to combat economic adulteration. Increased oversight, such as the use of technology to trace adulterated ingredients back to the point of contamination, could help FDA obtain more information on supply chains. FDA could also increase its regulatory and enforcement actions to address economic adulteration, including in instances that may not have a large negative public health impact. In addition, greater communication with industry through such means as an information clearinghouse or more informal interactions could enhance FDA efforts to gather information on economic adulteration.

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